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MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA), a Florida-based biopharmaceutical company with a market capitalization of $16.23 million, announced today the commencement of its Phase 1 clinical trial for Ketamir-2, an innovative oral ketamine analog aimed at treating neuropathic pain. According to InvestingPro data, the company maintains a strong liquidity position with a current ratio of 3.99, indicating robust short-term financial stability. The first participants have been enrolled at Hadassah Medical (TASE:BLWV) Center’s Clinical Pharmacology Unit in Jerusalem, Israel.
This randomized, double-blind, placebo-controlled study will evaluate the safety, tolerability, and pharmacokinetics of Ketamir-2 in healthy adult volunteers. The trial is set to include 56 subjects, with cohorts for Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) studies.
MIRA’s decision to move forward with human trials is backed by promising preclinical data. Ketamir-2 has shown superior efficacy in established neuropathic pain models when compared to FDA-approved treatments such as pregabalin and gabapentin. Furthermore, the compound exhibited a favorable safety profile, high oral bioavailability, and no interaction with P-glycoprotein (P-gp), which may enhance its ability to penetrate the brain.
The company expects to complete this initial phase by the fourth quarter of 2025 and plans to initiate a Phase 2a clinical trial focusing on diabetic neuropathic pain by the end of the same year. Efficacy data from the first human trials are anticipated in the first half of 2026.
This development marks a significant step for MIRA Pharmaceuticals in their pursuit of novel treatments for neuropathic pain, a condition that affects millions worldwide. The information reported is based on a press release statement.
In other recent news, MIRA Pharmaceuticals has announced a definitive agreement to acquire SKNY Pharmaceuticals. This acquisition will bring a novel oral drug candidate targeting weight loss and smoking cessation into MIRA’s pipeline. The deal involves a stock exchange, with SKNY merging into MIRA Pharmaceuticals, and includes a $5 million capital infusion from SKNY. Additionally, MIRA Pharmaceuticals has successfully developed a new topical treatment for localized neuropathic and inflammatory pain, derived from their drug Ketamir-2. This new formulation is part of their broader efforts in pain management, complementing an oral treatment currently undergoing a Phase 1 clinical trial. The trial, approved by the Israeli Ministry of Health, is assessing the safety and tolerability of Ketamir-2. MIRA is also preparing for a Phase 2a clinical trial in patients with diabetic neuropathy, expected to begin by the end of the year. These recent developments reflect MIRA Pharmaceuticals’ ongoing efforts to expand its therapeutic pipeline and address unmet medical needs.
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